Study onInformed Consent for Spaceflight Participants

Document Number: APT-CFA-230-0001-02F

September 26, 2008

(this page intentionally left blank)

i

1.0. LIMITATIONS/DISCLAIMER:

Within the scope of the engineering analysis reported here, A-P-T Research, Inc. warrants that we have exercised our best professional efforts at analyzing hazards and formulating conclusions. However, we must specifically disclaim any warranty, expressed or implied, that hazards will be completely eliminated or mishaps will be completely avoided or that any particular standard or criterion of hazard or mishap elimination or risk reduction will be achieved if the information presented here is taken as guidance. We do not accept liability for any loss, damage, or injury resulting from the use of this information.

As regards the legal analysis presented here, it is important for you to understand that the general opinions and commentary that are expressed in this report and its attached materials are NOT intended to be legal advice. The contractors have tried to identify appropriate cases and areas of law that impact the general field of informed consent in the context of the emerging commercial human space flight industry, but some information may have been missed or may be misinterpreted by us. Interpretations of the law are inherently subjective. Also, the law is in a constant state of flux and may change by the time you view or read these materials. Reading the attending materials is for educational purposes only and does not establish any type of recommendations from us to you on your own course of conduct nor does it establish any type of attorney client relationship between the contractors and yourselves. This information is intended to provide, to the best of our knowledge, accurate and authoritative information; we do not nor can we, however, guarantee the accuracy of the information contained in any of these materials. You should work with experienced legal counsel to provide advices on the law in your state or other related legal issues that may impact matters specific to your operation(s).

ii

TABLE OF CONTENTSLIMITATIONS/DISCLAIMER:........................................................................................................ ii1.0. PURPOSE............................................................................................................................ 12.0. DEFINITIONS....................................................................................................................... 1

2.1. Scientific/Mechanical 12.2. Legal 2

3.0. BACKGROUND DISCUSSION............................................................................................24.0. INFORMED CONSENT IN A LEGAL CONTEXT.................................................................4

4.1. The Phrase “Informed Consent” as it Derives from the Legal Context 44.2. Combining “Informed Consent” in Commercial Human Spaceflight with the Traditional Legal Framework of “Informed Consent” as Basis for Recommendations 7

5.0. SUMMARY AND RECOMMENDATIONS FOR SATISFYING REGULATORY REQUIREMENT............................................................................................................................. 96.0. HAZARDS.......................................................................................................................... 15

6.1. Physical Hazards to Spaceflight Participants 166.1.1. High G Forces..........................................................................................................196.1.2. Microgravity..............................................................................................................20

6.2. Psychological Response Hazards 226.3. Summary of Identified Potential Effects on Spaceflight Participants (SFPs) 22

7.0. FINAL SUMMARY AND “NEXT STEP” RECOMMENDATIONS:.....................................268.0. HAZARDS REFERENCE...................................................................................................27

LIST OF TABLES

Table 1. Summary of Physical Hazards to Spaceflight Participants.........................16Table 2. Summary of Psychological Response Hazards...........................................22Table 3. Potential Hazards - Probability of Occurrence.............................................23Table 4. Potential Hazards - Severity of Consequence...................................................25

iii

2.0. PURPOSE

This research project was initiated by FAA/AST to examine the issue of what a commercial space flight operator will need to do to satisfy the regulatory requirements of 14 CFR Part 460, specifically at §460.45(a)(1). APT Research, Inc. and Knutson & Associates were asked to research what is required to obtain or effectuate informed consent and to help educate the commercial space flight industry on the requirements of obtaining informed consent from space flight participants (SFPs). At §460.45(a)(1) the federal regulations require that the spaceflight participant be informed of each known hazard and risk that may result in serious injury, death, disability or total or partial loss of physical or mental function.

This study discusses, based on current industry practices and based on current legal precedents, the level of detail which should be used to describe the hazards and risks to a prospective space flight participant in order to satisfy the regulatory requirements. Additionally, this report describes the hazards and risks, as they are currently understood and contemplated, associated with suborbital commercial human space flight.

This study is not intended to be used as a legal template or considered to be a final authoritative FAA/AST-approved document. It does not cover any waiver of claims, exculpatory agreements, or similar agreements between the participant and the company providing the launch service. The purpose was to study the process of informing the participant of the hazards and risks, not the process of waiving liability. Very specifically, readers should understand that the mandate of informed consent is statutory and regulatory, so the focus of this study is simply how informed consent can be satisfied. This paper does not take any position on whether fulfillment of that mandate provides risk shifting or defenses from claims and this study makes no inquiry into other areas of risk shifting or defense such as release and waiver contracts or other common law defenses.

3.0. DEFINITIONS

3.1. Scientific/Mechanical

RISK – Risk characterizes the degree of harm posed to an asset (person, property, etc.) expressed as an Expectation of Loss that combines the potential Severity and the Probability of a loss event.

PROBABILITY – Probability is an expression of the likelihood of a loss event. Probability has no dimension and is therefore meaningless unless attached to a unit of exposure such as: hours of operation, miles driven, flights flown, widgets produced, etc.

SEVERITY – Severity is an expression of the magnitude of loss or harm associated with a potential event.

1

3.2. Legal

NEGLIGENCE - Negligence under the law is generally defined as the failure to use ordinary care; that is, failing to do what a person of ordinary prudence would have done under the same or similar circumstances. Essentially we are looking to determine whether an operator, guide or land administrator could or should have recognized an unreasonable risk and then did nothing to warn the participant or to reduce or eliminate the unreasonable risk. To examine negligence in behavior or conduct, look for 2 things: was the risk foreseeable and was the risk unreasonable.

DUTY - Duty generally refers to one party’s responsibility to take reasonable care for the protection of another party. Duty has 3 primary origins: 1.) from a relationship inherent in the situation; 2.) from a voluntary assumption; or 3.) from a duty mandated by a statute or regulation of some sort.

INHERENT RISK - Providers or operators have no duty to protect participants from inherent risks and no corresponding liability for injury or loss resulting from those inherent risks. Courts vary in their interpretation of this as a common law doctrine. Some hold that a participant doesn’t need to know and understand, in advance, the particular inherent risk. Others hold that participants have to have some type of subjective understanding of the specific risk causing the injury before the doctrine applies.

4.0. BACKGROUND DISCUSSION

The Phrase “Informed Consent” as it Applies to Commercial Human Spaceflight1

In drafting the Commercial Space Launch Amendments Act of 2004 (CSLAA), Congress found that: space transportation is “inherently risky” and that the public interest would be served by creating a “clear legal, regulatory and safety regime.”2 Congress also said that launch licensees/permittees (the operators) would have to obtain written “informed consent” from SFPs.3 On December 15, 2006, the FAA4 published Human Space Flight

1 Please note: a limited amount of the background material contained herein is similar to material contained in The Journal of Space Law (Tracey L. Knutson, "What is 'Informed Consent' for Space-Flight Participants in the Soon-to-Launch Space Tourism Industry?" 33 J. Space L. 105 (2007)). The Report's authors would like to acknowledge the Journal and the Journal's Executive Editor, who early-on recognized the topic as important and timely, and whose recommendations resulted in foundational research for this Report. 2 Id. at 70101(a)(12 & 14).3 Id. at 70105(b)(5)(A-C).4 The 1984 Commercial Space Launch Act established the Department of Transportation (DOT) as the Federal Agency responsible for regulating and overseeing the private commercial launch vehicle industry. See, 49 U.S.C. §2604 (1984). In 1984, DOT established the Office of Commercial Space Transportation (OCST) which reported to the Secretary of Transportation; then in 1995 OSCT oversight was delegated to the FAA Administrator who created the Office of the Associate Administrator for Commercial

2

Requirements for Crew and Space Flight Participants5, as Congress required in the CSLAA.6 The FAA’s final rule, which became effective on February 13, 2007, expressly states that “...before receiving compensation or agreeing to fly a space flight participant, an operator must inform each space flight participant in writing about the risks of the launch and reentry vehicle type. For each mission an operator must inform a space flight participant, in writing, of the known hazards and risks that could result in a serious injury, death, disability or total or partial loss of physical and mental function...[and] an operator should inform a space flight participant that there are also unknown hazards.... The operator also must disclose that participation in space flight may result in death, serious injury, or total or partial loss of physical or mental function. An operator must inform each space flight participant that the United States Government has not certified the launch vehicle and any re-entry vehicle as safe for carrying crew or space flight participants.”7 (Emphasis added.) This constellation of warnings the operators must give the space flight participants (SFPs) is what Congress and the FAA are calling “informed consent.”8 With respect to SFPs, the commercial human space flight industry is not required to obtain medical clearance on the space flight participants and must only give the written warnings noted above and obtain the participant’s written consent to participate.9 But note that the regulations also require what appears to be safety type discussions or question and answer sessions between the operator and the SFP.10 These two things, written consent and oral questioning of the operator, are clearly intended to achieve some type of “cognizance test” or “...affirmation that the space flight participant understands what he or she is getting into before embarking on a mission.”11

Space Transportation (now, “AST”). Currently the FAA has oversight and regulatory authority for this industry. The FAA’s authority to issue rules on commercial space transportation safety is found in Title 49 of the United States Codes, section 322(a), which authorizes the Secretary of Transportation to carry out Subtitle IX, Chapter 701, 49 U.S.C. 70101-70121 (Chapter 701).5 71 Federal Register 241 (Dec. 15, 2006).6 Commercial Space Launch Amendments Act of 2004, Pub. L. No. 108-492, 118 Stat. 3974 (2004); Human Space Flight Requirements for Crew and Space Flight Participants, Final Rule, 71 Federal Register 241 (Dec. 15, 2006).7 14 CFR §460.45 (2006).8 CFR §460.65 (2006); 49 U.S.C. §70105(b)(5)(A-C) (Supp.2004).9 See generally, 14 CFR 460.45 (2006).10 The Final Rule issued by the FAA also requires that before actual flight, licensed operators must also give SFP’s an opportunity to orally ask questions to enable them to better understand the hazards and risks of the “mission.” Id. at (f). 11 Again, see, Human Space Flight Final Rule, Description of Final Rule and Discussion of Comments II(C)(2)(a) on Launch and Re-entry With a Space Flight Participant, Informed Consent and the Space Flight Participant’s Ability to Be Informed, 71 Federal Register 241 (Dec. 15, 2006).

3

5.0. INFORMED CONSENT IN A LEGAL CONTEXT

5.1. The Phrase “Informed Consent” as it Derives from the Legal Context

Informed consent documents derive most commonly from medical or therapeutic regimes and these documents record that treatment risks have been disclosed and consent to the treatment has been obtained.12 If appropriate consent is in place then the medical or therapeutic provider has some protection from claims made regarding the “inherent risks” of the treatment, but no protections from negligence claims.13 What makes informed consent unique is that something is done to the participant by another party (usually the medical provider) with the participant’s consent.14

The right of a patient to informed consent has been a staple of U.S. medical malpractice law for over three decades.15 In order to establish a (prima facie) case that he or she has been deprived of informed consent, a claimant must prove that: 1) a doctor failed to disclose a material risk of the therapy undertaken or reasonable alternatives to it; 2) that the patient would have chosen against the recommended therapy; and 3) that as a result of the therapeutic intervention the patient suffered harm/injury.16 (Emphasis added to highlight application to current discussion on human spaceflight.)

Courts differ as to the standard that governs the determination of whether a risk is material such that it warrants disclosure to the

12 See generally, Law For Recreation and Sports Mangers, Third Edition, Doyice J. Cotten, John T. Wolohan, Chapter 2.24 on Inherent Risk Related Defenses: Informed Consent Agreements & Agreements to Participate. Kendall/Hunt Publishing Co., Dubuque, Iowa.13 Id.14 For other contexts in which courts have used the phrase “informed consent”, see also: Watkins v. Ford Motor Co., 190 F.3rd 1213, 1219 (11th Cir. 1999) (holding that purchaser of SUV should have been warned of rollover characteristics of the vehicle allowing him to make an informed choice whether to take the risks warned against); Borel v. Fibreboard Paper Prods. Corp., 493 F.2d 1076 1089 (5th Cir. 1973) (holding that asbestos benefits may outweigh risk but defendant is liable for failing to give workers an informed choice as to whether they wish to expose themselves to the risk); Williams v. Lederle Labs., 591 F.Supp 381, 383 (S.D. Ohio 1984) (holding that beneficial but dangerous drugs must be accompanied by adequate warnings of risk). 15 See, Margaret A. Berger and Aaron D. Twerski, Uncertainty and Informed Choice: Unmasking Daubert, 104 Michigan L. Rev. 257, 270-72 (2005), citing Allan H. McCoid, A Reappraisal of Liability for Unauthorized Medical Treatment, 41 MINN. L. REV. 381, 426-30 (1957). Prior to the McCoid article, there was no mention of informed consent in any of the major treatises or court decisions. 16 See, Canterbury v. Spence, 464 F.2d 772, 787-9 (D.C. Cir 1972), cert denied, 409 U.S. 1064 (1972); Williams v. Boyle, 72 P.3d 392, 397 (Colo. Ct. App. 2003); Barton v. Estate of Buckley, 867 So. 2d. 271, 272 (Miss. Ct. App. 2004); Grasser v. Kitzis, 553 A. 2d 346 (N.J. Super. Ct. App. Div. 1988); Scott v. Bradford, 606 P. 2d 554, 559 (Okla. 1979).

4

patient. Some jurisdictions measure materiality based on what information a ‘reasonable doctor’ would provide. Others refuse to cede to the medical profession the decision of what risks ought to be disclosed. Emphasizing that at the heart of an informed consent right is patient autonomy, they opt for a ‘reasonable patient’ standard to determine materiality. With regard to causation, courts are also not in agreement. Some require that for the causal nexus to be met, a plaintiff must establish that a ‘reasonable patient’ would have chosen against the therapeutic intervention. Other courts take the position that if the patient herself would have chosen otherwise, causation is established.

Commentators have argued that requiring the plaintiff to prove what decision would have been made had the material information been communicated to the plaintiff undercuts the goal of patient autonomy. The undeniable fact is that the patient was not provided with the information necessary to decide whether to undergo the therapy. The physician proceeded unilaterally. Though this argument is theoretically sound, as a practical matter the issue of decision causation is rarely decided against plaintiffs as a matter of law. It is almost always given over to the sound discretion of juries. The requirement that the plaintiff establish the causal connection between the therapeutic intervention and the injury actually suffered is almost never a matter of contention. Indeed it is only when the plaintiff suffers from the undisclosed risk that the plaintiff is moved to bring suit. The damages for failure to provide informed consent are measured by the unwarned-against adverse outcome that the plaintiff suffered.17

It is generally accepted that the doctrine of informed consent is rooted in the principle that every person has the right to determine what shall be done to his (or her) own body. See, Schloendorff v. Society of New York Hospitals, 105 N.E. 92 (1914). “True consent to what happens to oneself is the informed exercise of a choice, and that entails an opportunity to evaluate knowledgeably the options available and the risks attendant upon each.” LaCaze v. Collier, 434 So. 2d 1039 (1983).

Looking at a few individual cases clarifies some of these issues and highlights the effect of traditional informed consent. In a Louisiana case entitled Hondroulis v. John Schumacher, M.D., 521 So. 2d 534 (1988) an appellate court examined the specificity that needed to be in an informed consent document. The Hondroulis case involves a woman who signed a consent form prior to undergoing a lumbar laminectomy; when the procedure resulted in permanent complications the woman sued the doctor, claiming among other things, that the doctor had not obtained her informed consent because he had failed to disclose the specific complication she suffered after the surgery (the consent form expressed that she could suffer loss of function of bodily organs, paralysis and loss of function of any arm or leg; she specifically experienced loss of bladder control and left leg numbness). The Hondroulis court quoted from a state statute defining informed consent (to medical treatment) as being “a consent in writing to any medical or surgical 17 See, Margaret A. Berger and Aaron D. Twerski, Uncertainty and Informed Choice: Unmasking Daubert , 104 Michigan L. Rev. 257, 270-72 (2005). Citations omitted.

5

procedure or course of procedures which (a) sets forth in general terms the nature and purpose of the procedure or procedures, together with the known risks, if any, of death, brain damage, quadriplegia, paraplegia, the loss or loss of function of any organ or limb, of disfiguring scars associated with such procedures or procedures, (b) acknowledges that such disclosure or information has been made and that all questions asked about the procedure or procedures have been answered in a satisfactory manner and (c) is signed by the patient for whom the procedure is to be performed.” The claimant, Hondroulis, then challenged the court by saying that the statutory language (and therefore the consent form which the doctor had required her sign and which tracked the state statute language) was not adequate to obtain her informed consent where it did not name the particular/specific organ or limb that was damaged as a result of her surgery. The reviewing court found that where the informed consent document that was given to Hondroulis tracked the language of the state statute it was considered legally adequate. Very specifically the reviewing court found that “…the requirement of specific disclosure of all organs that are known to be at risk during a surgical procedure would do violence to the legislative intent to provide a clear statutory test for informed consent. If we place this requirement on health care providers, whatever certainty was created by [the statute] would be destroyed, forcing doctors and hospitals to compile long lists of every possible body organ which could be affected by any given medical procedure…. Faced with this list, which would resemble a book on anatomy, a patient’s consent would not be any anymore informed than if a form which tracks the statutory language was read to or by the patient before consent was obtained.” The Hondroulis decision also made clear that written informed consent (under the LA statute) had to include an acknowledgement that the medical care recipients’ questions had all been answered in a satisfactory manner.

The Hondroulis case stands for the proposition that both parties to a transaction (here health care provider and patient) are involved in a “give and take.” Specifically, health care providers (at least at the time the Louisiana legislature passed its medical informed consent statue) were seeking some certainty in how they informed patients and that, in exchange for them ensuring that basic information on risks were transferred to the patient, then some relief from liability would be afforded. The case recognizes the (Louisiana) legislature’s earlier statutory attempt to balance the rights of patients and the rights of the physicians. The case also recognizes that too much information is not helpful to a patient with limited medical knowledge and that, because medicine is not an exact mechanical science, doctors may not be able to predict each and every possible effect to a patient. And finally, the requirement that a patient be given the opportunity to ask questions and receive satisfactory answers must be acknowledged in the written informed consent document.

In a 1995 case, a Texas court discussed the constitutionality of a state statute that required only minimum style disclosures and found that “Disclosure of risks in compliance with the statute creates a rebuttable presumption that the physician was not negligent...”[and] “…only material risks need be disclosed; a physician cannot be expected to disclose all risks, including those for which the risk is so minimal that it would not influence a reasonable person’s decision.” See, Pennick v. Chritensen, M.D., Pfizer Hospital Group, et al. 912 S.W. 2d 276 (1996).18 The Pennick Court, quoting the earlier case of Peterson

18 See also, Spar v. Jin S. Cha, M.D., 881 N.E. 2d 70 (Indiana 2008), holding that

6

v. Shields, 652 S.W. 2d 929 (1983), expressly stated that the “…disclosures provided by statute are governed by the same standard as under common law: a patient is entitled to know those risks that could influence a reasonable person in making a decision to consent to the procedure in question.”

It is also notable that the legal cause of action for (violation of…) the duty to obtain informed consent stands separate and apart from a claim that the (physician) operator or defendant was negligent in either recommending or performing a given action.19 As such, the use of the phrase “informed consent” as it has been used by Congress and the FAA (as opposed to simply requiring operators to comply with a negligence based “duty to warn;” see, §3.2, below) has most likely created a separate independent tort or cause of action against commercial operators.

5.2. Combining “Informed Consent” in Commercial Human Spaceflight with the Traditional Legal Framework of “Informed Consent” as Basis for Recommendations

It is first important to understand that Congress expressly stated that the emerging commercial human space flight industry was not to be viewed as highly regulated transportation like the airline industry but rather was comparable to adventure travel;20

Congress even went so far as to compare the participants to daredevils, visionaries and adventurers.21 In stating that space flight is inherently risky, Congress mandated at 49 USC §70105(b)(5)(A-C) (Supp. 2004) that space flight participants must be informed of the risks of spaceflight and must sign an informed consent form. It is fairly clear that Congress’ real concern with commercial human space flight was not in presenting the infant space flight industry as a provider setting out to “do” anything to participants (see,

“Physicians have a duty to make a reasonable disclosure of material facts relevant to the decision the patient is required to make.” And, “The doctrine of informed consent is based on the patient’s right to intelligently accept or reject treatment.” Citations omitted.19 See, Aaron D. Twerski & Neil B. Cohen, Informed decision Making and the Law of Torts: The Myth of Justiciable Causation, 1988 U. ILL. L. Rev. 607, 616-17 (1988).20 See, 70 Federal Register 249, 77269 (Dec. 29, 2005) wherein the FAA expressly states that the CSLAA characterization of “Space Flight Participant” “...signifies that someone on board a launch vehicle or re-entry vehicle is not a typical passenger with typical expectations of transport, but someone going on an adventure ride.” This section of the Proposed Rule also quoted Michael Kelly as “...characterizing the experience as an adventure ride.” And the Proposed Rule stated at that section that “[O]thers have compared it to mountain climbing, skydiving, not wearing a helmet while riding a motorcycle, and other risky endeavors.”21 See, Space Travel Law and Politics: The Evolution of the Commercial Space Launch Amendments Act of 2004, Timothy Robert Hughes and Esta Rosenberg, Journal of Space Law Volume 31 (2005), quoting at pg. 46 Rep.(s) Boehlert and Rohrbacher as testifying, respectively, in the Congressional Record that the commercial human space flight industry “...is like a baby in its crib...” and the “...industry is at the stage when it is the preserve of visionaries and daredevils and adventurers...who will fly at their own risk [and]...who do not expect and should not expect to be protected by the government.”

7

discussion above at §3.1, pg. 7) but rather as a young industry that had no established community standards or customary practices so that the importance of warning participants of the risks and dangers was very recognizable. As such, it seems that Congress really intended to impose on operators a statutory or codified “duty to warn” when it used the phrase “informed consent.” It is important to note though, that we rarely see the phrase “informed consent” actually used in the adventure sport context;22 more often adventure sport operators (and the courts reviewing them when claims are made) rely on negligence oriented principals or defenses such as assumption of the risk and exculpatory documents like release and waiver contracts. In the context of the emerging commercial human space flight industry, however, because Congress used the phrase ”informed consent” and because that phrase has legal meaning, we extrapolate from the common legal context in which informed consent normally appears (the medical or therapeutic regimes).

According to the common law on negligence (standard duty to warn analysis)23 as it has developed around the country, it is fair to say that the standard of care for commercial recreation or adventure sport operators is that they have a duty to inform/warn guests of the risks that they are taking in participating in an activity.24 One of the most common allegations in lawsuits against outdoor oriented operations is that they “failed to warn” and “inform” participants of the risks involved and/or failed to give adequate instructions. Operators must inform guests of the risks that they are taking in participating in an activity. It is clear that explaining/instructing/warning is really the foundation of minimizing or mitigating risks associated with any activity. Thus, the “standard of care” anticipates that a reasonable and prudent commercial adventure operator carrying out the

22 But see, B&B Livery, Inc. v. Riehl, 960 P.2d 134, 140 (1998), a Colorado case examining a contractual release agreement in the context of a suit for damages deriving from a fall from a rented horse, wherein the dissent mentions the phrase informed consent in discussing of scrutiny of the language of the release contract.23 Negligence under the law is generally defined as the failure to use ordinary care; that is, failing to do what a person of ordinary prudence would have done under the same or similar circumstances. Essentially we are looking to determine whether an operator, guide or land administrator could or should have recognized an unreasonable risk and then did nothing to warn the participant/student or to reduce or eliminate the unreasonable risk. To examine negligence in behavior or conduct, look for 2 things: was the risk foreseeable and was the risk unreasonable. See, Law For Recreation and Sports Managers, Third Edition, Doyice J. Cotten, John T. Wolohan, Chapter 2.10 on Negligence Law. Kendall/Hunt Publishing Co., Dubuque, Iowa.24 Duty generally refers to one party’s responsibility to take reasonable care for the protection of another party. Duty has 3 primary origins: 1.) from a relationship inherent in the situation; 2.) from a voluntary assumption; or 3.) from a duty mandated by a statute or regulation of some sort. See generally, Law For Recreation and Sports Mangers, Third Edition, Doyice J. Cotten, John T. Wolohan, Chapter 2.11 on Elements of Negligence. Kendall/Hunt Publishing Co., Dubuque, Iowa. And see, Licato v. Eastgate, 499 N.Y.S. 2d 472 (A.D. 3 Dept. 1986); Saffro v. Elite Racing Inc., 98 Cal. App. 4th 173 (Ct. App. California, May 7, 2002)(rev. denied, 2002 Cal. Lexis 5268 (July 2002)).

8

same activity will inform a participant of the risks. With respect to delivering warnings or informing participants (a form of risk management25), obviously there’s a correlation in where you spend the most energy - at the areas that produce the most frequent or the most severe risks.26

With reference to the “informed consent” common law in the United States and then with reference to the issue of a commercial adventure sport or activity operator’s “duty to warn,” the following section provides recommendations as to the level of detail and/or information that should be provided or given to space flight participants to satisfy the “informed consent” requisite found at 14 CFR §460.45 (2006).

6.0. SUMMARY AND RECOMMENDATIONS FOR SATISFYING REGULATORY REQUIREMENT

Again – in the context of the developing commercial human space flight industry, Congressional history and statutory interpretation make clear that the purpose behind the current regulatory requirement that commercial human space flight operators obtain written informed consent from their perspective customers (“space flight participants” or “SFP’s”) before exchanging funds or making further agreements or contracts with them is intended to satisfy a more commonly recognized “duty to warn.” Specifically, it is intended to inform a SFP of risks that may affect the SFP’s own decision as to whether the activity and/or the risks attendant with the activity are worth encountering. The clear intent here is to arm the perspective SFP with enough information to allow them to make the decision to participate and/or encounter these risks.

A review of the case law and codified law (statutes) from around the country27 on informed consent make the following premises clear. First – the basic parameters of informed consent are: “a consent in writing to any… procedure or course of procedures which (a) sets forth in general terms the nature and purpose of the procedure or

25 It’s important to grasp the concept that the level of risk management correlates to the tolerance of any given group/operator and its guests for risk. If risk is mitigated to a point below a particular level of tolerance, guest or student or participant experiences and satisfaction will be affected or changed. See, Legal Liability and Risk Management in Adventure Tourism, Ross Cloutier with Daniel Garvey, Will Leverette, James Moss and Gilles Vadade, 2000, Chapter Eight on Risk Management, page 96. Bhudak Consultants, Kamloops, British Columbia. Remember, it is not that you have a duty to ensure your participants/guests are kept away from all risk, rather that they are not exposed to risks which in your business would be considered unreasonable.26 See, Legal Liability in Recreation and Sports, Second Edition, Bruce B. Hronek and John O. Spengler, 2002, Chapter One on Overview of Trends, Risk and Legal Liability, quoting from pages 22-23. Sagamore Publishing, Champaign, Illinois.27 Please note that informed consent statutes, case law and law review articles exist in abundance and are, quite literally, too numerous and exhaustive to be reviewed and/or discussed in this report; illustrative cases have been selected and discussed with the intention of conforming to the limited inquiry and to the limited resources assigned to this project.

9

procedures, together with the known risks, if any, of death, [injury or other damages] (b) acknowledges that such disclosure or information has been made and that all questions asked about the procedure or procedures have been answered in a satisfactory manner and (c) is signed by the [participant] for whom the procedure is to be performed.”28 As such, the elements of a (prima facie) legal cause of action claiming that an operator/provider breached the duty to obtain informed consent and/or that a participant has been deprived of informed consent will include claims that: 1) an operator/provider failed to disclose a material risk of the activity undertaken or reasonable alternatives (mitigation) to it; 2) that the participant would have chosen against the activity had they been informed; and 3) that as a result of the activity the participant suffered harm/injury.29

It is noteworthy though, that courts find that only material risks need be disclosed; an operator/provider cannot be expected to disclose all risks, including those for which the risk is so minimal that it would not influence a reasonable person’s decision.30

And, when considering whether informed consent has been obtained (and/or given to the participant) courts routinely find that where there are statutes or regulations in place that govern the amount of information that must be given to a person from whom informed consent is being sought and where a provider satisfies those statutory and regulatory disclosure guidelines, there is created a presumption in favor of the operator that informed consent was obtained.31 In other words, compliance with statutory or regulatory wording is usually thought sufficient to constitute informed consent. Second – it is reasonably clear that informed consent style disclosures are intended to contain or discuss material risks, those risks that would influence a reasonable person in making a decision to participate or to consent to participation.32 Informed consent is not intended to include disclosure of all risks and so will not require warnings for which the risk is minimal enough that it wouldn’t influence a reasonable person’s decision making process.33 Third, the regulations and case law on informed consent also require that the participants be allowed an opportunity to request information and to orally ask questions and receive satisfactory answers to questions; that these opportunities have been provided must be acknowledged in the written document.34

28 See, Hondroulis v. John Schumacher, M.D., 521 So. 2d 534 (1988).29 See, Canterbury v. Spence, 464 F.2d 772, 787-9 (D.C. Cir 1972), cert denied, 409 U.S. 1064 (1972); Williams v. Boyle, 72 P.3d 392, 397 (Colo. Ct. App. 2003); Barton v. Estate of Buckley, 867 So. 2d. 271, 272 (Miss. Ct. App. 2004); Grasser v. Kitzis, 553 A. 2d 346 (N.J. Super. Ct. App. Div. 1988); Scott v. Bradford, 606 P. 2d 554, 559 (Okla. 1979). 30 See, Pennick v. Chritensen, M.D., Pfizer Hospital Group, et al. 912 S.W. 2d 276 (1996).31 Id. at 521 So. 2d 534, 536 (1988), citing Leonard v. New Orleans East Orthopedic Clinic, 485 So. 2nd 1008 (La. App. 4th Cir. 1986); and. Pennick v. Christensen, M.D., 912 S.W. 2d 276, 284 (Tex. App. 1995). 32 See, discussion above at §4.1, pg. 10, above.33 Id.34 The Final Rule issued by the FAA also requires that before actual flight, licensed

10

The express language in the regulation currently states (paraphrasing) that “...before receiving compensation or agreeing to fly a space flight participant, an operator must inform each space flight participant in writing (the information has to be presented in a manner that can be readily understood by a SFP with no specialized education or training) about the risks of the launch and reentry vehicle type. For each mission an operator must inform a space flight participant, in writing, of the known hazards and risks that could result in a serious injury, death, disability or total or partial loss of physical and mental function...[and] an operator should inform a space flight participant that there are also unknown hazards.... The operator also must disclose that participation in space flight may result in death, serious injury, or total or partial loss of physical or mental function. An operator must inform each space flight participant that the United States Government has not certified the launch vehicle and any re-entry vehicle as safe for carrying crew or space flight participants.”35 According to the Final Rule, the written information or warning must state that the vehicles being used will not have undergone nearly the amount of testing that normal commercial travel style vehicles undergo before they are licensed for commercial use and must discuss the safety records of all launch and re-entry vehicles that have carried one or more persons as well as the safety record of the specific vehicle being used. Then, the Rule requires that operators inform participants that they may request additional information and must be given an opportunity to orally ask questions to better understand the risks of the flight/mission. Standard acknowledgements (dated signatures) must also be obtained36 as well as acknowledgements that the SFP understands the risks and that the SFP acknowledges that his/her participation or presence on the launch vehicle is voluntary.37

Beyond these express regulatory requirements and in concert with legal intention of “informed consent,” (notifying participants of material risks that would influence a reasonable person’s decision making on a particular activity) where it is clear that one of the primary hazards or risks associated with this young industry is that there are no accepted standards guiding the industry regarding critical concerns like the physical condition of the SFP, what gear the SFP should be required to wear, what safety equipment should be in the vehicle, what is required in a safety briefing, what type of vehicle is capable of routinely traveling to suborbital space, or even what specific categories of aircraft or specific instrument ratings a pilot must have,38 SFPs should be

operators must also give SFP’s an opportunity to request additional information on accidents and incidents and must be allowed to orally ask questions to enable them to better understand the hazards and risks of the “mission.” 14 CFR §460.45 (e) and (f).35 14 CFR §460.45 (2006).36 See, §460.45(b)&(c).37 See, 14 CFR Part 460.45(f).38 The FAA flight crew guidelines simply recommend that pilots have a pilot’s license with instrument rating and aeronautical experience, a second class airman medical certificate and be thoroughly trained in all aspects of the flight systems. It is notable too that pilots and crew on carrier aircraft, if any, will not be considered crew for purposes of the regulations. See, 14 CFR §460.5 and Description of Final Rule and Discussion of

11

appraised of this dearth of standardized knowledge, awareness and response. Participants need to know that this industry and the hybrid technologies it is creating are experimental at best. The listing of risks that a SFP should be informed of needs to expressly state or explain the fact that the safety of those on board is largely unregulated and is considered by law makers to be the province of “daredevils, visionaries and adventurers.”39 The warnings need to give the information that the reason there is little to no regulation is because the industry is not seen by the Federal Government as anything akin to the airline or transportation industry. SPFs should be made to understand that they should not view their participation as a definite ride from point A to point B, but rather as an experience where the end result is getting to space,40 however briefly or momentarily. Furthermore, the warnings need to expressly state that it has been reliably estimated there will be somewhere in the neighborhood of a 1 in 200 failure rate or higher.41 As to the seeming disparity in these figures, it should noted that, though space vehicle flight failures usually result in death of the occupants, the vehicle failure rate is expected to be lower than the fatality rate for two reasons: first, Space vehicle failures may result in multiple fatalities (IE, Challenger, Columbia, and, if included in the data set, the Apollo 1 ground fire would also be an example) and second, many of those who have flown to space in the U.S. and Russian space programs have done so numerous times. The warnings must say that the entire space industry is really only 40 years old and in that time a fatality rate of just over 4 percent has emerged between the U.S. and Russian space programs with fewer than 450 people having flown to space, 18 of whom perished,42 demonstrating that the estimates of failure are reliable.43 To that end, the SFPs should understand that they, quite

Comments at II B 3 (2006). And see, The Safety Dance by Jeff Foust, February 21, 2005 Volume of the Space Review, available at pointing out that one of the key aspects of the CSLAA is the limitation on the FAA to regulate crew and passenger safety, that FAA/AST guidelines and drafts are not specifications and quoting former Secretary Norman Mineta saying that the FAA does not want “...to stifle industry...” with over-regulation.39 See, supra, note 18; and see, Space Tourism and Informed Consent: To Knowingly Go, by Laura Montgomery as published in the Transportation and Transportation Security Law Section’s newsletter, Translaw, Spring 2004 Issue.40 Id.41 See, Weighing the Risk of Human Spaceflight by Jeff Foust, July 21, 2003 available at and One Former Astronaut’s Perspective available at with former astronaut and space shuttle pilot Rick Hauck stating that he doubts he would have flown to space if he had known of the 4% fatality rate then.42 Id.; and see, Supra Notes 27 & 29.43 In the later portions of the warning document where acknowledgments are made, the SFP should be required to acknowledge that they have been advised to prepare or update their wills and to otherwise put their affairs in order. See, Space Tourism and Informed Consent: To Knowingly Go, by Laura Montgomery as published in the Transportation and Transportation Security Law Section’s newsletter, Translaw, Spring 2004 Issue wherein Greg Maryniak, executive director of the X-Prize Foundation is quoted as having stated/contemplated during an FAA conference that prospective space flight participants

12

literally, are part of the testing process and they need to see themselves as visionaries and daredevils who are willing to pay, beyond just the $200,000 ticket cost,44 the ultimate price.

The express warnings should also notify the SFP of their potential financial liabilities for a catastrophic incident where the risk sharing regime45 established in CSLAA declines to extend the conditional governmental risk sharing regime provided to operators to the SFP’s.46 While informed consent law and the Final Rule require warning participants that they, quite literally, may die participating in suborbital spaceflight as we currently know/understand it, the issue of abandonment and/or repatriation of mortal remains are topics that rarely receive enthusiastic discussion. However, in the context of providing and obtaining informed consent, the potential death of participants should be discussed among all flight participants; recalling that one of the most important preparations for adventure style travel is full and complete warning/disclosure, it is necessary that all participants clearly understand what the likelihood of repatriation will be and what the potential cost to their families or survivors will be if body repatriation is desired (or even possible).

should receive pre-flight notices advising them to make out their wills.44 See, Space Tourism Survey Targets Cost Factor by David Leonard, October 23, 2006 on MSNBC, available at quoting a basic price tag for a Virgin Galactic space liner seat at roughly $200,000.45 See, Space Tourism and Informed Consent: To Knowingly Go, by Laura Montgomery as published in the Transportation and Transportation Security Law Section’s newsletter, Translaw, Spring 2004 Issue, stating that “...by excluding space flight participants from eligibility for indemnification by the federal government against third party claims, H.R. 3752 declines to subsidize the passenger.” And quoting testimony from Raymond Duffy Jr., a senior vice president for Willis InSpace Underwriters during committee testimony that “[i]f someone is willing to participate in commercial human space flights at this stage of its development then the risk should be dealt with solely between the passenger and the launch provider.” And quoting a House report that notes: “...space flight participants wishing to ride on board a launch vehicle have chosen to undertake a risky venture of their own accord. As such, they do not merit the financial security provided by the promise of indemnification. Moreover, space flight participants are not subject to any substantive government regulation.” And see, Space Travel Law and Politics: The Evolution of the Commercial Space Launch Amendments Act of 2004, Timothy Robert Hughes and Esta Rosenberg, Journal of Space Law Volume 31 (2005), at pg. 59 stating that “The 2004 Space Act allows individuals to undertake space flight at their own physical and financial risk. Space flight participants are excluded from indemnification eligibility under the 2004 Space Act and are not entitled to the benefits of liability insurance coverage.”46 Does the public really understand this yet? How many of the millionaires who will likely make up the first wave of space tourism will actually be willing to bet the farm, or the kids’ financial future knowing this fact?

13

This entire discussion, of course, also means that the more physically oriented risks associated with space flight need to be outlined; participants will need to be informed of and acknowledge things like illness at certain g-force levels, the possibilities of radiation exposure, the physical stresses of re-entry, the emotional or psychological risks associated with space travel and of extreme or adventure travel with fellow SFPs for whom the strains may be unpredictable.47 (See generally, §5.0 below, listing physical risks categorized by severity and frequency). It should be plainly and expressly conveyed that the stresses to the human body of even suborbital flight are, in and of themselves, still not completely defined.

Again, where the intent here is to satisfy a more commonly recognized “duty to warn,” looking at how warnings are done in the traditional adventure sport context is illustrative. Duty to warn can usually be accomplished by: setting good policies or rules, posting warnings on equipment or facilities, oral warnings, good documentation like release and waiver documents, encouraging safe participation, making sure that all participants and spectators are aware of the inherent risks of the sport. An effective warning is thought to be: specific, obvious and direct, unambiguous, easy to understand, simple and complete. Suggestions include: laminating your instructions on cards so guides/instructors don’t forget something, recording or taping safety briefings for consistency and creating (warning/instruction) witnesses who mark off a checklist and then sign/acknowledge that the guide/instructor has covered all of the requisites on the list.

Before participants actually engage in activities, guides/instructors/staff generally conduct safety talks or briefings. The basic outline of a good safety talk generally includes:48 1) specifics of the activity: area, weather, what can be expected on the trip, inherent dangers/risks, proper equipment use, proper techniques demonstration, what to do in the event of an emergency, that clients/participants must follow the guide/instructors directions at all times; 2) participant responsibilities: the level of physical involvement, confirmation that no one has a medical or physical condition that would prevent their participation or ability to help in the event of an emergency, explanation that no drugs or alcohol are to be consumed during activity, that guests must notify guides/operator of any problems with equipment or other guests and that they must report any incidents or accidents; and 3) a closing - confirm everyone signed the informed consent, release and/or other forms the operation requires, ask about additional questions they might have, arrive at consensus that the group understands and accepts what is required of them in the activity and that they accept the risks of the activity,

47 See, Supra, Note 38, The Safety Dance by Jeff Foust, February 21, 2005 Volume of the Space Review, available at discussing the Medical memorandum released by the FAA. See also, Making Space Happen – Private Space Ventures and the Visionaries Behind Them by Paula Berinstein, Plexus Publishing 2002, Chapter 3 You Can’t Throw Your Socks on the Floor in a Spacecraft by Harvey Wichman and Chapter 4 Space and the Body: Are We Robust Enough to Venture Out?

48 See, State of Risk, Risk Management in the Outdoor Industry, produced by Knutson & Associates; www.traceyknutson.com

14

provide an “out” for participants who do not want to participate so that participation is voluntary.

7.0. HAZARDS

This section summarizes the hazards to Space Flight Participants (SFPs) that have been identified by research of space flight experience. It is understood that space flight is inherently risky and that adverse physical and psychological effects can be experienced even during successful space flights. There are also numerous vehicle or system failures that could result in severe injury, dismemberment, or death of the SFP.Section 6.1 summarizes identified physical hazards and Section 6.2 presents potential psychological hazards that have been identified. There are two tables in Section 6.3 that summarize these hazards from two perspectives: Probability of Occurrence and Severity. In addition to these identified hazards, the SFP may experience adverse effects that have not been identified.

7.1. Physical Hazards to Spaceflight Participants

Table 1 provides a listing of the identified physical hazards to SFPs. Of the physical hazards listed, two in particular have potentially complex effects on SFPs and warrant a more complete discussion of the hazard mechanism: exposure to High G Forces and Microgravity (see Sections 6.1.1 and 6.1.2).

Table 1. Summary of Physical Hazards to Spaceflight Participants

Source of Physical Hazard Mission Phase and/or Failure Mechanism Causing Hazard

Potential Physical Effects

High Decibel Noise Excessive engine noiseInadequate acoustical shieldingExplosion on ground

Ear drum damageTemporary or permanent hearing lossVestibular effects on balance

High Pressure Breached high-pressure vesselExplosionIn-flight aerodynamic pressure

Loss of consciousnessSevere ear drum or tissue trauma due to overpressureConcussionBrain damageDeath

15

Source of Physical Hazard Mission Phase and/or Failure Mechanism Causing Hazard

Potential Physical Effects

Low Pressure Explosive decompressionLoss of cabin pressure due to leakLoss of atmospheric control systems

Trauma due to exposure to vacuum:

Brain or spinal cord injury (temporary or permanent)

Lung injury Other tissue damage Death

Trauma due to pressure change and trapped gas:

Gastrointestinal pain Tooth, ear and sinus pain Potential tissue damage

in affected areas

High G-forces (Sustained Acceleration)

Acceleration during launch phase, de-acceleration during descent phase (due to grab of aerodynamic control surfaces)

G-Profile over flight may have adverse physiological and/or pathological effects particularly on the cardiovascular response of compromised participants.49 (See details in section 6.1.1.)

Cardiovascular Neurovestibular Musculoskeletal

49 The duration of acceleration exposure is a critical factor in evaluating human tolerance to high accelerations. In general, acceleration pulses of less than 200 milliseconds are considered to be “impacts,” and greater accelerations can be tolerated as the duration decreases. For acceleration exposures beyond a couple of seconds, it is physiological fluid dynamics that show the greatest negative effect. See Wyle Lab Technical Report #LS-09-2006-001, AST Commercial Human Space Flight Biomedical Data Collection (2007), pp. 15 & 23.

16

Source of Physical Hazard Mission Phase and/or Failure Mechanism Causing Hazard

Potential Physical Effects

Microgravity At high altitudes during sub-orbital flight.

Short exposures to microgravity may cause acute physiological responses in several bodily systems (details of these are provided in Section 6.1.2) 50 • Cardiovascular • Respiratory • Neurological: o Vestibular o Motion Sickness o Vision • Musculoskeletal • Hematological • Psychological • Gastrointestinal SFPs may expect these symptoms: - Unfamiliar effects on physical movement - Internal displacement/ entrapment of body fluids- Decreased gravity-dependent circulation in lower extremities- Changes in the chemical makeup of blood

High Temperature On-ground fire or explosionIn-flight fire or explosionHeat of re-entry and loss of heat dissipation systems

Tissue damage Serious burns – including third degreeDeath

Low Temperature Cabin breach, loss of heating systems

Frost-biteDeath

High Radiation levels Shielding not adequate High radiation levels in space

Radiation sicknessLoss of bodily fluidsIncreased long-term cancer riskDeath

Sunlight Prolonged looking at unfiltered sunlight

Eye damage

50 See Wyle Lab Report, p.17.

17

Source of Physical Hazard Mission Phase and/or Failure Mechanism Causing Hazard

Potential Physical Effects

Physical Impact Trauma- AIS 5,651

Crash or structural failure of spacecraft (due to system failure, pilot error, weapons fire, impact with space debris, etc.)

Serious injury or death

- AIS 3,4 Ground or In-flight – numerous mechanisms

Moderate injury

- AIS 1,2 Entry/exit from spacecraft Minor injury

Exposure to Toxic Chemicals

Release of toxic substance on-board or from ground storage tanks

Respiratory or skin damageDeath

Electrical shock Contact with exposed high voltage source of electrical potential (on-board or on ground)

Severe burnsElectrocution / Fatality

Loss of breathable atmosphere/change in composition of atmosphere/contaminants and particulates

Loss of atmospheric control systems and backup systemsCabin flooded with non-breathable gases

Asphyxiation / FatalityBrain and other organ damageDeath

Loss/damage of personal effects on board or at launch site

On-pad explosion and/or nominal launch effects to participant property on ground (cars, jets, vehicles)

Loss of assets

7.1.1. High G Forces52

The main risks for problems with acceleration in aerospace flight are associated with the neurological, cardiovascular, and musculoskeletal systems. To avoid the potential for compromising neurological function, acceleration forces are preferably applied in the front-to-back (+Gx) direction (eyeballs in). An individual is very tolerant to +Gx acceleration, and with the heart and brain located at approximately the same level within the acceleration field there is little risk for acceleration (G)-induced loss of consciousness. Acceleration stress is known to be dysrhythmogenic (changes in cardiac rate, rhythm, and conduction). Higher and longer exposures to acceleration increase the frequency of dysrhythmias. As long as the head, neck, and spine are stabilized before the acceleration exposure and remain so until the exposure is completed, the potential for musculoskeletal injury is markedly reduced.

51 The Abbreviated Injury Scale (AIS) is commonly used to rate the severity of an injury.52 See DOT/FAA/AM-06/01, Guidance for Medical Screening of Commercial Aerospace Passengers (2006), p.1.

18

An individual’s tolerance to head-to-foot (eyeballs down) acceleration (+Gz) is dependent on the individual’s anatomic and physiologic characteristics and the nature of the acceleration profile. The maximum +Gz level, exposure duration, and the rate of onset of the +Gz are important determinants of the risk of neurologic compromise, cardiac rhythm disturbances, and musculoskeletal (especially neck) injury. Onset-rates greater than 0.1G/second are considered rapid, since they exceed the ability of the cardiovascular system to fully respond to preserve adequate central nervous system blood flow. Rapid-onset rates of 1.0G/ second and greater can result in loss of consciousness without visual warning symptoms.

Conservative relaxed, unprotected tolerance of completely healthy humans to +Gz acceleration is considered approximately +3Gz (normal range 3.1 to 4.0) for rapid onset profiles and increases to approximately +3.5Gz (normal range 3.7 to 5.6) with gradual-onset profiles. Individuals with compromised cardiovascular anatomy or function may have reduced tolerances. Care should be exercised with rapid-onset profiles to +3Gz or more, sustained for 5 seconds or longer.

7.1.2. Microgravity53

On the basis of the existing data and the known effects of acceleration and microgravity on human physiology, the most important human biological system parameters to be monitored before, during, and after flight are cardiac, pulmonary, musculoskeletal, neurovestibular, and psychological.54 Gastrointestinal issues must also be addressed. Interestingly, the reported illness frequency seen in commercial aviation indicates the most common illness is gastrointestinal (22.3%), with cardiovascular (21.8%) and respiratory (10.2%) illnesses still relatively prevalent. Since space flight participants are likely to reflect the general aviation public, we may see a similar distribution of illness.55

This information supports evaluation of the likelihood of various effects of space flight.

Cardiovascular and Respiratory Systems

The cardiovascular system will be immediately affected by suborbital short-duration flight, as discussed earlier. As a result, this is the most significant physiological data point that should be monitored to characterize effects on space flight participants. This will, when possible, include in-flight monitoring of cardiac function. The commercial jet aircraft cabin altitude pressurization limit is 8,000 ft above MSL pressure, which is also likely in suborbital spacecraft. SFPs with compromised conditions such as chronic obstructive pulmonary disease (COPD) should be aware that participation in space flight may adversely affect their respiratory system. A recent study concluded that a substantial proportion of older passengers - up to 44 percent of healthy passengers aged 65 years or more - may have inadequate arterial oxygen levels at 8,000 feet above MSL pressure, while breathing cabin air. However, it is important to put this in perspective. In the

53 See Wyle Labs Report, p.17-18.54 Johnston R., “Clinical Aviation Medicine: safe travel by air”, Clinical Medicine, Vol. 1, No 5, 2001.55 Cummings R.Q., et al, “In-flight deaths during commercial air travel”, I Am Med Assn, 1998.

19

context of civil commercial aviation, it is accepted in general that passengers who can walk 50 meters on the level or climb 10 steps without dyspnea should be able to tolerate the relative hypoxia at commercial aircraft pressurization levels.56 This information supports evaluation of personal risk levels by potential SFPs – especially those having less than robust respiratory systems.

Neurovestibular and Muscular Systems

The dynamic force environment of space flight will also manifest itself with effects on the neurovestibular and muscular system. While short term, they may have a significant impact on participants. This is particularly relevant as participants are likely to have an active role in aspects of vehicle operations related to health and safety. For example, participants may be expected to return to their designated seats after a period of weightlessness and reattach their own harness for reentry. In addition, they may be expected to egress the vehicle without assistance upon landing, or take particular action in an emergency situation. Avoiding adverse neurovestibular effects is important to ensure that the participants are able to comply with safety instructions especially during reentry and at landing. SFPs should be informed of the hazards associated with the potential inability to perform these functions.

Hematological System

Previous space flight experience has shown that there are unlikely to be significant changes to the endocrine, hematological, and immunological systems as a result of short-duration suborbital flight, except where extreme change in volume status (i.e. dehydration/volume overload) plays a significant role. SFPs should be informed of the additional hazards associated with dehydration during space travel and the importance of proper hydration prior to embarking.

Psychological Effects

Previous space flight and analogs have shown that some experienced crew suffered from acute anxiety to disabling psychosis in reduced gravity and/or confined environments. The potential for similar effects on non-professional SFPs should be disclosed to potential SFPs to support personal evaluation of the associated hazards.

Gastrointestinal Effects

Experiences of previous space flight and commercial airline participants have shown that the most common acute illness encountered is gastrointestinal in nature. Potential SFPs should be informed that their participation will likely result in some degree of gastrointestinal distress. In a microgravity environment such illnesses may represent an additional collective risk to all occupants in the vehicle from uncontrolled release of bio-hazardous material. SFPs should be informed that they may be exposed to the results of other participant’s illnesses.

56 Muhm J. M. “Predicted Arterial Oxygenation at Commercial Cabin Altitudes,” Aviation, Space, and Environmental Medicine, Vol. 75, No. 10, pp. 905-912, Oct. 2004.

20

7.2. Psychological Response Hazards

Spaceflight participants may experience excessive physiological/psychological response(s) during the spaceflight. Participants prone to responses that could be hazardous to themselves or others should be identified and appropriate measures taken to minimize the risk of the hazards. Table 2 provides some examples of this type of hazard.

Table 2. Summary of Psychological Response Hazards

Source of Physiological/Psychological

Response Hazard

Potential Cause of SFP Response Potential Effects of Physiological/Psychological

Response

Claustrophobia Prolonged enclosure in confined space

Excessive agitation

Possible inability to perform required duties

Excitement/Agitation/Fear Response to unexpected occurrences.

Response to known risks.

Mental instability.

Commit irrational and possibly violent, acts. Produce anxiety in other participants.

Possible inability to perform required duties/ incapacitation

Motion Sickness Spacecraft in dynamic motion Nausea, vomiting.

Possible inability to perform required duties/ incapacitation

Vertigo - loss of bearing or balance

Spacecraft in dynamic motion Nausea, vomiting.

Possible inability to perform required duties/ incapacitation

Rapid pulse/Increased blood pressure

Excitement Cardiac arrhythmia

Possible inability to perform required duties/ incapacitation

Possible heart failure

7.3. Summary of Identified Potential Effects on Spaceflight Participants (SFPs)

As noted by Congress in drafting the Commercial Space Launch Amendments Act of 2004 (CSLAA), space transportation is inherently risky. Approximately 4% of those who have flown in space to date have lost their lives doing so. Commercial space travel opportunities clearly pose the risk that a system or vehicle failure might result in serious injury or death. Such failures have a wide variety of potential causes – a few examples include: propulsion system or structural failures, explosion of propellants on the ground or in the vehicle, loss of vehicle control, ground impact, and collision with space debris.

The identified potential hazards of participation in space flight have been more fully described in Sections 6.1 and 7.2. Tables 3 and 4 rank these effects based on their probability of occurrence and the severity of the resulting consequence. These subjective

21

rankings are based on typical expectations and may vary from one operator to another as well as from an individual space flight participant to another.

Table 3. Potential Hazards - Probability of Occurrence

PROBABILITY of OCCURRENCE

PROBABLE / CERTAIN Gastrointestinal issues – microgravity Dysrhythmia (changes in cardiac rate, rhythm, and conduction) - acceleration stress Excitement and euphoria Exposure to actions of other SFPs

SOMEWHAT LIKELY Motion sickness - microgravity Faint feeling – acceleration Headaches – low pressure Fatigue – low pressure Muscle strain – acceleration Minor injury during entry / exit from craft Panic / Fear / Fright Electrical shock Loss / damage to personal effects on ground

POSSIBLE Loss of consciousness – acceleration Moderate injury – ground failure or impacts within craft Connective tissue damage – acceleration Vertigo – loss of bearing / balance Exposure to dangerous wildlife – launch site locality Significant pulmonary/respiratory effects – microgravity Severe weather – launch site locality Cardiovascular effects – acceleration/microgravity Claustrophobia Inability to think rationally High altitude sickness – launch site locality Heatstroke / Dehydration / Sunburn – launch site locality Vestibular effects – vertigo / balance – noise

RARE – MOST LIKELY CAUSED BY VEHICLE OR SAFETY SYSTEM FAILURE Death / Critical injury / Dismemberment – failure Asphyxiation – loss of cabin atmosphere Temporary or permanent hearing loss Bone fractures – acceleration Eye damage – unfiltered sunlight

22

PROBABILITY of OCCURRENCE

Burns due to ground accident Ear drum damage Radiation sickness – exposure to space radiation

23

Table 4. Potential Hazards - Severity of Consequence

SEVERITY of CONSEQUENCE

CRITICAL Death / Critical injury / Dismemberment Asphyxiation Permanent hearing loss Bone fractures Loss of consciousness

SIGNIFICANT Moderate injury due to ground failure or impacts within craft Connective tissue damage due to acceleration Exposure to dangerous wildlife Eye damage – unfiltered light Ear drum damage Temporary hearing loss Heatstroke / Dehydration / Sunburn Burns due to ground accident Radiation sickness – exposure to space radiation Vestibular effects – vertigo / balance Electrical shock

NUISANCE Exposure to actions of other SFPs 9depending on situation – could be significant)

Dysrhythmia (changes in cardiac rate, rhythm, and conduction) – could be significant in certain SFPs Motion sickness Faint feeling Headaches Fatigue Muscle strain Panic / Fear / Fright Minor injury during entry / exit from craft Claustrophobia Inability to think rationally Loss / damage to personal effects on ground High altitude sickness Severe weather

There is significant variation in the human response to the conditions encountered when preparing for or participating in space flight; some SFPs may be more or less susceptible to these conditions/reactions. In addition to hazards and risks identified in this section, the inaccessibility of medical care at the remote sites utilized for commercial space flights is a consideration when assessing personal risks of participation in commercial space flight.

24

Finally, there are numerous adverse effects that could arise from participation in a successful space flight. Many of these are known risks, but there may be other risks that have not yet been identified.

8.0. FINAL SUMMARY AND “NEXT STEP” RECOMMENDATIONS:

Because the regulation mandates written informed consent and, legally speaking, informed consent only provides legal protection (defense) from the inherent risks of an activity and not from negligence, there is some confusion as to whether any private contract (release and waiver document) that seeks pre-activity exculpation from inherent risks and negligence (standard in the adventure world) would be valid. Where the Appendices to the Final rule provide exculpatory style documents in favor of the government as the permitting agency, there is reason to believe that exculpatory documents between a commercial operator and a SFP would be allowed. How these documents would legally interact with and/or be affected by the requisite of written informed consent needs to be clarified. An additional issue is how the requisite of written informed consent may affect other defenses that would normally be available to a commercial operator – like assumption of the risk.

It is clear that the Courts differ as to the standard that governs the determination of whether a risk is material such that it warrants disclosure to the patient. Specifically, materiality is sometimes based on what information a ‘reasonable doctor’ would provide and in other jurisdictions the ‘reasonable patient’ standard determines materiality. Clarification of how materiality gets satisfied – either by what the operator believes is material or by what the SFP thinks is material should be provided.

Collaboration with industry may well be necessary or expedient at this point. Where it has been widely publicized that a leading suborbital provider has signed up literally thousands of prospective SFP’s and has begun working with them, or at least working with some of their “founders,” using this early group to determine or establish materiality may well be revealing for industry.

Finally, this report and these recommendations are provided as an example only and are not intended to be used as a legal template or considered to be a final authoritative or FAA/AST approved document. Individual operators should work with experienced legal counsel to provide advices on how the law in your state or other related legal issues may impact matters specific to your operation(s).

25

9.0. HAZARDS REFERENCE

Antunano, M.J., et al., “Guidance for Medical Screening of Commercial Aerospace Passengers,” DOT Office of Aerospace Medicine, Washington D.C., January 2006.

Bagshaw, M., “Telemedicine in British Airways,” J Telemedicine Telecare, 1996;2(1); pp36-8.

Cummings R.Q., et al, “In-flight deaths during commercial air travel,” I Am Med Assn, 1998;259;1983-8.

Hanada et al., Arrhythmias Observed During High-G Training: Proposed Training Safety Criterion. R. Aviation, Space, and Environmental Medicine, Vol. 75, No. *, pp.688-691, Aug 2004.

Johnston R., “Clinical Aviation Medicine: safe travel by air,” Clinical Medicine, Vol. 1, No. 5, 2001.

Jurist, J. “Human factors in commercial suborbital flight: What does acceleration do to the human body?” The Space Review, www.thespacereview.com/article/402/1, Tuesday, July 5, 2005.

Lugan, B.F. and White, R.J., “Human Physiology in Space,” National Space Biomedical Research Institute, www.nsbri.org/HumanPhysSpace, undated.

McDonald, P.V., et al., “AST Commercial Human Space Flight Participant Biomedical Data Collection,” Wyle Laboratories, Inc., Technical Report #LS-09-2006-001, February 1, 2007.

26